Senior Director, Clinical Operations Business & Excellence

The Role:

Generate is seeking a Senior Director, Clinical Operations Business & Excellence to set the strategy for, establish, and lead a centralized Clinical Operations Business Office that embeds inspection readiness into clinical trial execution. This role will be accountable for the Business Office operating model, governance, and portfolio-level performance across that may include clinical sourcing and vendor governance, site contracts and budgets, trial master file operations, standard operating procedures, operational quality, monitoring oversight, risk and issue management, and corrective and preventive action (CAPA) follow-through. By establishing consistent metrics, processes, and clear accountability, the role will strengthen documentation traceability, enable timely identification and remediation of risks, and maintain sustained inspection readiness across the clinical portfolio.

Reporting into the head of Clinical Operations and partnering with development leadership and Quality, you will shape organizational inspection readiness. You will translate clinical portfolio priorities into scalable processes, clear accountabilities, and measurable improvements in quality, timeliness, and cost. In addition, you will anticipate the capabilities required as the portfolio evolves, recommend investment and resourcing priorities, and lead execution against agreed outcomes.

This role combines strategic judgment with hands-on execution and requires close collaboration across study teams, Clinical Development, Quality, Regulatory, Biometrics, Finance, Legal, Procurement, and technology partners. You will serve as a senior cross-functional leader, align stakeholders on complex operational decisions, and integrate commercial, financial, and quality insights into portfolio-level priorities. You will build the team capabilities, partnerships, and governance needed to scale the Business Office while enabling study teams to focus on advancing medicines for patients.

Here's how you will contribute:

Clinical Business Office & Financial Management

Set the strategy and lead the Business Office operating model. Define responsibilities, decision rights, service expectations, and handoffs with study teams. Own the Business Office roadmap, annual objectives, and performance measures. Lead resource and capability planning, including recommendations on internal capabilities and external service models, aligning priorities with clinical portfolio needs and reducing duplication across programs. Adjust the operating model as portfolio complexity and organizational needs evolve.

Vendor Governance & Site Contracting

· Be involved in commercial strategy and complex contracting decisions. Oversee and contribute to business negotiations for master service agreements, statements of work, and amendments in partnership with Legal, Procurement, and Finance. Establish clear deliverables, financial assumptions, performance expectations, and change-control practices within approved authorities. Set consistent negotiation and escalation practices, resolve material commercial issues, and evaluate cross-program implications of major commitments and changes.

· Own the centralized site contracting and budgeting operating model in partnership with service providers and internal teams. Oversee clinical trial agreement workflows, investigator budget templates, and negotiation practices to improve consistency, support appropriate site reimbursement, and accelerate study startup. Establish service expectations and performance measures, identify recurring bottlenecks, and lead cross-functional improvements that scale across the portfolio.

· Provide senior-level vendor governance and partnership leadership. Establish governance forums, key performance indicators, service expectations, and escalation pathways. Lead strategic business reviews and serve as a senior escalation point for material vendor performance issues. Drive recovery plans and recommendations on partnership continuation, expansion, or transition, engaging executive sponsors when decisions exceed delegated authority or carry significant portfolio implications.

Trial Master File & Continuous Inspection Readiness

· Own the electronic trial master file governance strategy and business process. Oversee eTMF structure, filing standards, document ownership, completeness, timeliness, and data integrity. Partner with Quality and technology teams on business requirements, access, retention, and reliable record retrieval. Establish portfolio-wide accountabilities and performance expectations, and prioritize process and system improvements based on risk and business needs.

· Lead a portfolio-wide approach to continuous inspection readiness. Establish risk-based TMF health checks and quality metrics, working with study teams and vendors to resolve gaps throughout study conduct and closeout. …